U.S. patent number 10,866,164 [Application Number 16/658,736] was granted by the patent office on 2020-12-15 for biodegradable sterile sampling bag.
This patent grant is currently assigned to LABPLAS INC.. The grantee listed for this patent is LABPLAS INC.. Invention is credited to Danielle Lafond, Shoreh Parandoosh, May L. Scally.
United States Patent |
10,866,164 |
Scally , et al. |
December 15, 2020 |
Biodegradable sterile sampling bag
Abstract
A biodegradable sampling bag for containing samples or the like,
comprises a flexible enclosure defining a chamber adapted to
contain therein the sample, the flexible enclosure being made of a
plastic material, which contains an additive that renders the
flexible enclosure biodegradable when exposed for a sufficient
period of time to microbial action. The additive is adapted to
enable microorganisms to metabolize the molecular structure of said
flexible enclosure. The additive is effective in altering the
polymer chain of the plastic material to allow microbial action of
a suitable environment to colonize in and around the plastic
material, whereby microbes can then form a biofilm on a surface of
the flexible enclosure and secrete acids which break down the
entire polymer chain. The flexible enclosure, when exposed to
microbial action, is adapted to withstand biodegradation for a
given period of time, typically of at least three months.
Inventors: |
Scally; May L. (St. Mathias sur
Richelieu, CA), Parandoosh; Shoreh (Mont
Saint-Hilaire, CA), Lafond; Danielle (Mont
Saint-Hilaire, CA) |
Applicant: |
Name |
City |
State |
Country |
Type |
LABPLAS INC. |
Sainte-Julie |
N/A |
CA |
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Assignee: |
LABPLAS INC. (Sainte-Julie,
CA)
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Family
ID: |
1000005244085 |
Appl.
No.: |
16/658,736 |
Filed: |
October 21, 2019 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20200158601 A1 |
May 21, 2020 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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15357488 |
Nov 21, 2016 |
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14522229 |
Oct 23, 2014 |
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13498812 |
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PCT/CA2010/001533 |
Sep 28, 2010 |
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Foreign Application Priority Data
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Sep 28, 2009 [CA] |
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2680970 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
B65H
45/12 (20130101); B29D 22/003 (20130101); C08L
23/06 (20130101); C08K 3/012 (20180101); C08J
5/18 (20130101); C08K 5/0033 (20130101); G01N
1/02 (20130101); Y10T 428/1345 (20150115); C08J
2323/06 (20130101); B29K 2023/0633 (20130101); C08K
2201/018 (20130101); B29K 2995/006 (20130101) |
Current International
Class: |
G01N
1/02 (20060101); B29D 22/00 (20060101); C08K
3/012 (20180101); B65H 45/12 (20060101); C08L
23/06 (20060101); C08J 5/18 (20060101); C08K
5/00 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Robert Leaversuch, "Additive Masterbatches Make Polyolefins
Degrade", Plastics Technology, Oct. 2002. cited by applicant .
Robert Sinclair, "Additive Technology for Polyolefin
Biodegradation" presented at 2004 PLACE conference, TAPPU,
URL:http://www.tappi.org/content/enewsletters/eplace/2004/02-2Sinclair.pd-
f. (The year of publication is sufficiently earlier than the
effective U.S. filing date so that the particular month of
publication is not an issue.). cited by applicant .
ECM BioFilms, Inc., "ECM MasterBatch Pellets ECM6.0701", Material
Safety Data Sheet, Validation Date: Jul. 10, 2007. cited by
applicant.
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Primary Examiner: Krcha; Matthew D
Attorney, Agent or Firm: Bereskin & Parr
LLP/S.E.N.C.R.L., s.r.l.
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATIONS
The present application is a continuation application of U.S. Ser.
No. 15/357,488 filed on Nov. 21, 2016, that is a continuation
application of U.S. Ser. No. 14/522,229 filed on Oct. 23, 2014,
that is a continuation application of U.S. Ser. No. 13/498,812
filed on Sep. 11, 2012, that is a 371 national stage entry of
international application PCT/CA2010/001533 filed on Sep. 28, 2010,
that claims priority to Canadian Patent Application No. 2,680,970
filed on Sep. 28, 2009. These documents are all hereby incorporated
by reference in their entirety.
Claims
The invention claimed is:
1. A biodegradable sampling bag for containing a sample containing
microbes, the biodegradable sampling bag consisting of: a flexible
enclosure defining a chamber adapted to contain therein the sample
containing microbes, said flexible enclosure being made of a
plastic material, said plastic material containing an additive that
renders said flexible enclosure biodegradable when exposed for a
sufficient period of time to microbial action, said plastic
material encouraging growth of the microbes in the sample when the
sample is contained in the flexible enclosure, and said plastic
material configured to provide the flexible enclosure to withstand
biodegradation for a period of 20 weeks when exposed to the
microbial action from the microbes in the sample and to biodegrade
in nine months to five years when exposed to microbial action of a
disposal environment.
2. A biodegradable sampling bag as defined in claim 1, wherein said
additive enables microorganisms to metabolize the molecular
structure of said flexible enclosure.
3. A biodegradable sampling bag as defined in claim 2, wherein said
additive has altered the polymer chain of said plastic material to
allow microbial action of a suitable environment to colonize in and
around said plastic material, whereby microbes can then form a
biofilm on a surface of said flexible enclosure and secrete acids
which break down the entire polymer chain.
4. A biodegradable sampling bag as defined in claim 3, wherein the
microbial action eventually converts said flexible enclosure into
carbon dioxide and water when subjected to aerobic biodegradation,
and into carbon dioxide, methane and water when subjected to
anaerobic biodegradation.
5. A biodegradable sampling bag as defined in claim 4, wherein said
flexible enclosure, when exposed to microbial action, remains
transparent for the period of time.
6. A biodegradable sampling bag as defined in claim 5, wherein said
bag is sterile.
7. A biodegradable sampling bag as defined in claim 6, wherein said
plastic material is Low-Density Polyethylene (LDPE) sheet
material.
8. A biodegradable sampling bag as defined in claim 6, wherein said
plastic material is Linear Low-Density Polyethylene (LLDPE) sheet
material.
9. A biodegradable sampling bag as defined in claim 8, wherein said
plastic material comes in the form of tubing for manufacturing said
flexible enclosure.
10. A biodegradable sampling bag as in claim 9, wherein said
additive comprises ethylene-vinyl acetate copolymer with additive
ingredients being organoleptic-organic compounds, cultured colloids
and natural fiber.
11. A biodegradable sampling bag as defined in claim 10, wherein
said flexible enclosure is sealed except at one portion thereof
which comprises bag access means for substantially sealing said bag
in a first position thereof but also selectively allow in a second
position thereof the sample to be introduced in said chamber when
it is desired to use said bag, whereby once in said second position
the sample can be received in said bag.
12. A biodegradable sampling bag as defined in claim 11, wherein
said access means comprises a detachable tear off strip.
13. A biodegradable sampling bag as defined in claim 12, wherein
said strip includes sealing means for sealing said bag in said
first position but be removed from said bag with said detachable
strip in said second position thereby opening said bag at said one
portion thereof for subsequent receipt of the sample therein.
14. The use of a plastic material containing an additive for making
a biodegradable sampling bag, wherein the plastic material
containing said additive is configured to provide for
microorganisms to metabolize the molecular structure of said
sampling bag and cause said sampling bag to biodegrade in a period
of nine months to five years and to provide for the sampling bag to
withstand biodegradation for a period of 20 weeks when the sampling
bag is exposed to microbial action of a sample contained within the
sampling bag, the plastic material encouraging growth of microbes
in the sample when the sample is contained in the sampling bag;
wherein the use comprises making the biodegradable sampling bag
using said plastic material.
Description
FIELD OF THE INVENTION
The present invention relates to bags and, more particularly, to
sterile sampling bags for use in handling sample materials and the
like (such as clinical samples), for instance in laboratories, in
hospitals, in the food industry, etc.
BACKGROUND OF THE INVENTION
Sterile sampling bags are used to collect, contain and carry a
variety of sample materials that are pertinent to the agro-food,
pharmaceutical, medical and environmental industries. These
industries are all subject to various regulatory bodies, such as
the FDA in the United States of America, Health Canada, HCAPP, etc.
These regulators ensure that all products intended for consumption
or interaction with the general public (either directly, such as
food products, or indirectly, such as chemical fertilizers), meet
scientific and measured standards that confirm their safety.
In order for a sampling bag to be viable for these industries, the
following specifications should be met: made from virgin materials;
does not, in any way, interfere with the integrity of the substance
being tested; does not leach any altering chemicals, such as
cadmium, mercury, lead, etc., into the substance it is carrying;
sterile (therefore harbors no fungus, mold, aerobic or anaerobic
bacteria); the producer provides a sterility certificate and ensure
production lot number traceability for the entire shelf life of the
sampling bag; when used for DNA detection, must be R-Nase, D-Nase
and pyrogen free; physically viable: not porous, able to contain a
specific range of PH and acidity levels; typical shelf life of 3
years minimum, under ambient storage conditions, before use; and
sufficiently elastic and of low tear propensity to accommodate the
pressures of a laboratory homogenizer.
In order to better understand these requirements, the following is
a typical description of a field application for the use of a
sampling bag.
At varying and predetermined intervals during any given food
production process, samples of the food matter will be collected
using sanitary methods and by inserting the substance in a sterile
sampling bag. This occurs at many stages of the process, from the
raw material phase, throughout the process and again with the final
product. Furthermore, work surfaces, production and handling
machinery and packaging materials are also sampled for testing.
Essentially, these components are all being tested to ensure that
no harmful pathogens (such as E. coli, Listeria, Salmonella) or
chemicals are present. Typically, various nutritive solutions are
added to the sample substance and it is then transported to a
laboratory for incubation and subsequent microbial analysis. The
sampled material can be retained in a sampling bag for a wide
variety of time periods. Usually, this consists of a few days,
however, in some cases the sample can be retained for months, such
as in a freezer environment.
Such sampling bags are typically made of plastics material and thus
constitute a significant concern, when discarded, for the
environment.
Therefore, there is a need for a sampling bag that is friendlier to
the environment.
SUMMARY OF THE INVENTION
It is therefore an aim of the present invention to provide a
biodegradable sampling bag that will respect a sufficient number of
the aforementioned criteria, depending on the intended use of the
bag.
Therefore, in accordance with the present invention, there is
provided a biodegradable sampling bag for containing samples or the
like, comprising a flexible enclosure defining a chamber adapted to
contain therein the sample, said flexible enclosure being made of a
plastic material, said plastic material containing an additive that
renders said flexible enclosure biodegradable when exposed for a
sufficient period of time to microbial action.
Also in accordance with the present invention, there is provided a
method of making a biodegradable sampling bag, comprising the steps
of: a) producing a flexible enclosure from a plastic material
containing an additive that renders said flexible enclosure
biodegradable when exposed for a sufficient period of time to
microbial action; and b) making a bag from said flexible enclosure,
said bag defining a chamber adapted to contain therein a
sample.
Further in accordance with the present invention, there is provided
for the use of a plastic material containing an additive for making
a biodegradable sampling bag, wherein the plastic material
containing said additive is adapted to enable microorganisms to
metabolize the molecular structure of said sampling bag and cause
said sampling bag to biodegrade, but being adapted, when exposed to
microbial action, to sustain biodegradation for a given period of
time.
Other objects, advantages and features of the present invention
will become more apparent upon reading of the following
non-restrictive description of embodiments thereof, given by way of
example only.
BRIEF DESCRIPTION OF THE DRAWINGS
The drawings included herewith are for illustrating various
examples of articles, methods, and apparatuses of the present
specification. In the drawings:
FIG. 1 is a schematic representation of a sampling bag.
DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS OF THE INVENTION
The sampling bag of the present invention, such as the sampling bag
B shown in FIG. 1, is produced with virgin Low-Density Polyethylene
Low-Density Polyethylene (LDPE) tubing which includes a specially
formulated technology that incorporates nutrients and other
compounds which alter the polymer chain to allow microbial action
to colonize in and around the plastic. Microbes can then form a
biofilm on the surface of the plastic and secrete acids which break
down the entire polymer chain, converting the material into inert
humus (biomass), CO.sub.2, methane and water. The sampling bag B
includes a flexible enclosure 10 defining a chamber 12 adapted to
contain therein a sample.
The present sampling bag has a similar five year shelf life as
conventional bags. The biodegradation of the plastic is not
triggered by heat, light, or moisture. Furthermore, the sampling
bag was submitted to 20 weeks of intense exposure to laboratory
conditions (inoculation with various fungi, moisture, bacteria) and
remained physically and chemically intact. The sampling bag is
sterile and is also R-Nase, D-Nase and pyrogen free.
The additive technology does not activate until the sampling bag is
disposed of in a compost or sewage environment. Biodegradation
under these conditions occurs over a period of, for instance, nine
months to five years, depending on the concentration of
microorganisms in the disposal environment.
Biodegradable Plastic Technology and the Sampling Bag Challenge
Plastic materials and polymers are rendered biodegradable through
the addition of substances that impact their molecular structures.
The goal is to sufficiently weaken or interrupt their polymer
chains in order to allow environmental factors to interact with
them for eventual degradation. Unadulterated polymer chains do not
otherwise lose their molecular structure, and therefore are
believed to remain intact within our ecological systems (landfills,
sewage, general environment) for indefinite periods.
The very concept of attempting to produce/develop a biodegradable
sampling bag is counterintuitive to the requirements of the
scientific community and stability that the bag must possess (see
list of aforementioned specifications).
Beyond the characteristics required of a sampling bag, during the
course of its useful life, the bag will be subjected to a wide
variety of materials, liquids and ambient conditions. These
sampling bags are used by the scientific community, a group that is
extremely knowledgeable and, understandably, not prone to
modifications of proven tools and methodology. Analytical results,
scientific validations and public security are reliant on the
integrity of the entire testing process, including the sterile
sampling container.
The Technological Challenges
Most current biodegrading catalyst agents known today are
cellulose-based and many are heat and/or light activated. One known
agent enables bacterial interaction. This summary will examine all
three as to their potential application for the production of
biodegradable sampling bags.
1) Cellulose is a plant-derived base, therefore of organic origin.
This technology causes two factors that make it inappropriate for
consideration when searching for a method to produce biodegradable
sampling bags: the plastic material becomes rigid in structure,
with no elasticity and tears too easily; and there is significant
risk of traces of organic material in the plastic, which would
significantly interfere with the substances being sampled and
tested in the food, chemical, medical and pharmaceutical
industry.
2) Heat and Light activated additives present a particular
challenge and are also inappropriate: plastics are produced through
melting of granule mixtures and consequent extrusion. Any
biodegradable plastics produced with this type of heat-activated
additive begin to degrade as soon as they are produced. The
resulting material is indeed biodegradable; however, it is unstable
and has a very short shelf life; and furthermore, under normal
shelf storage conditions, the plastic will be exposed to light,
which will further hasten its degradation.
3) Bacteria Enabling Catalyst:
In the present invention, Applicant has identified a biodegradable
additive produced by Biofilms, commercialized under the name
MasterBatch Pellets.TM., which enables microorganisms in the
environment to metabolize the molecular structure of plastic
products. The plastic degrades through the action of aerobic and
anaerobic bacteria, and is not rendered unstable by light or heat.
The plastic, in this case Linear Low-Density Polyethylene (LLDPE)
remains stable, pliable and sufficiently transparent for the
sampling bag application.
However, this additive also bears a potential challenge and is very
counterintuitive to being viable for the microbiological analyses
industry, in that sampling bags are used to enhance and encourage
the growth of bacteria and other microorganisms, in order to detect
their presence; and if the plastic material of the bag begins to
degrade when in contact with such active bacteria, how can a
sampling bag provided with the aforementioned biodegradable
additive be considered as even remotely viable for this
application?
The Solution
The ECM Biofilms biodegrading additive is the more promising of
these types of additives on the market; however, two inherent
questions had to be answered in order for the product technology to
be applicable for a sampling bag application: does the sampling bag
retain the minimum levels of physical and chemical characteristics
required in order to be viable? how long will the biodegradable
sampling bag remain intact once it is in contact with bacteria,
Fungi, mold or other microorganisms?
Proofing Methodology and Outcomes
Applicant obtained biodegradable LLDPE tubing produced with the ECM
Biofilms additive.
Physical Validation:
Applicant's production team applied this raw material to its
conventional production process with the following results: the
material performed well when running through Applicant's bag making
technology; print ink adheres very well to the surface and is
retained thereon for a sufficient period; Applicant's tape and wire
closure system adheres well to the surface of the biodegradable
LLDPE; and the resulting sterile bag is still sufficiently
transparent and has the appropriate and, to the naked eye, has the
required physical appearance.
Scientific Validation of the Physical Attributes
Base Testing:
First, Applicant's standard, FDA approved, non-biodegradable LLDPE
film was subjected to a series of physical and chemical tests to
confirm various measurements as a control test against which to
measure and control the same attributes for the new biodegradable
film of the present invention.
Next, the biodegradable LLDPE film was subjected to the same
physical, chemical and biological testing, in order to obtain its
baseline physical measurements.
Base Test Results of the biodegradable film: has met the United
States of Pharmacopeia (USP) 29, National Formulary (NF) 24
criteria for physical testing; is R-Nase, D-Nase and pyrogen free,
per test results from the outside laboratory, Mobio; has an MVTR
(Moisture Vapor Transmission Rate) value of 0.38 g/100
in.sup.2/day, which is comparable to Applicant's standard
(non-biodegradable) material which has an MVTR value of 0.32 g/100
in.sup.2/day; and has an OTR (Oxygen Transmission Rate) value of
381 cc/100 in.sup.2/day which is comparable to Applicant's standard
material which has OTR results of 480 cc/100 in.sup.2/day.
Testing of Product Viability and Integrity (under market conditions
and applications):
The additive used to render the LLDPE film biodegradable, enables
microorganisms to digest and break down plastic molecular
structures. Applicant's sterile sampling bags are used to gather
food, water, and other substances, and to actually incubate them in
order to allow any present microorganisms to multiply and form
colonies. Samples and related substances can remain in the bag from
periods of a few hours to a few months.
ECM Biofilms states that products manufactured with their
biodegrading catalyst remain stable and have similar shelf lives to
their non-biodegradable counterparts. They also claim that the
treated material will biodegrade in nine months to five years
(depending on the plastic polymer, its thickness, and the
composting, sewage, or disposal environment conditions where
microorganisms are present). Applicant needed to ensure that the
sampling bags would retain their physical integrity for the useful
life thereof, i.e. from the moment a sample is inserted inside, to
the time of disposal, which is usually less than three days but
which could, however, range up to a few months.
Product (sampling bags) samples of the present invention were
submitted to three consecutive months of exposure to
microorganisms, molds and fungi, and, once a month, some pieces
were submitted to physical testing in order to measure tensile
strength, MVTR (Moisture Vapor Transmission Rate) and OTR (Oxygen
Transmission Rate). All testing was performed by outside firms.
The results of the physical tests at the end of each month have
confirmed that the biodegradable plastic material of the present
invention remains physically unchanged when exposed to
laboratory-like applications and microorganisms for a minimum
period of three months.
In light of these confirmed results, Applicant considers that the
present biodegradable Low Density Polyethylene has been
scientifically validated, that it meets market and scientific
requirements, and that it can be used for at least three months
without any degradation.
Although the present invention has been described hereinabove by
way of embodiments thereof, it may be modified, without departing
from the nature and teachings of the subject invention as described
herein.
* * * * *
References